Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in Persons With HIV

• Status: Terminated
• Trial end date: 2017-06-28
• Target enrollment: 0
• Participant gender: All

Summary

There is a rapidly-growing need to identify evidence-based, safe, and effective co-treatment regimens for HIV-related tuberculosis (TB) among patients who require protease inhibitor (PI)-based antiretroviral therapy (ART). This study compared three alternative co-treatment options among participants in high TB endemic resource-constrained settings, in which one co-treatment option explores if an additional anti-HIV drug needs to be used when patients are being treated with a PI together with rifabutin-based anti-TB treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AIDS Clinical Trials Group
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Ethambutol; Isoniazid; Lopinavir; Pyrazinamide; Pyridoxine; Raltegravir Potassium; Rifabutin; Rifampin; Ritonavir; Vitamin B 6

Criteria

Inclusion Criteria:

• HIV-1 infection

• CD4+/CD8+ T-cell count obtained within 30 days prior to study entry

• Confirmed or probable pulmonary or extrapulmonary TB (more information on the criterion can be found in the protocol)

• Chest x-ray within 30 days prior to study entry

• A PI-based antiretroviral regimen is required, as determined by the participant's primary clinician/clinical facility

• Certain laboratory values obtained within 14 days prior to study entry (more information on the criterion can be found in the protocol)

• For females of reproductive potential, negative serum or urine pregnancy test within 7 days prior to study entry and 72 hours of starting study medications

• Willing to use acceptable methods of contraception while on study drugs and for 6 weeks after stopping these drugs

• Karnofsky performance score > 40 within 14 days prior to study entry, and likelihood of survival, in the opinion of the site investigator, for at least 6 months

• Ability to swallow oral medications

• Ability and willingness of participant or legal guardian/representative to provide informed consent

Exclusion Criteria:

• History of completed TB treatment and resolution of TB symptoms less than 1 year prior to the current TB episode at study entry, or incomplete treatment for a prior episode of TB (i.e., defaulted past TB treatment) at any time prior to the current TB episode

• Documented multidrug-resistant tuberculosis (MDR TB) or extensively drug-resistant tuberculosis (XDR TB)

• Participants infected with a rifamycin resistant strain of TB (more information on the criterion can be found in the protocol)

• Receipt of more than 28 cumulative days of anti-TB treatment for the current TB episode prior to study entry

• Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements

• Active illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry, or that in the opinion of the site investigator, might otherwise interfere with adherence to study requirements

• Pregnant or breastfeeding

• Anticipated receipt of prohibited medications (more information on the criterion can be found in the protocol)

• Known intolerance/allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations

• History of close contact with known MDR or XDR TB patients at any time prior to study entry